Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage

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Brief Title

Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage

Official Title

"A Prospective, Cross-over Randomized Trial to Assess the Efficacy and Safety of Mechanical Percussor "LEGA" Compared With Conventional Chest Physiotherapy in Adults With Chronic Bronchiectasis or Chronic Obstructive Pulmonary Disease (COPD

Brief Summary

      A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine
      which is supposed to mimic the chest percussion performed by professional physiotherapist to
      mobilize sputum through the respiratory passage.

      The aim of this study is to compare the effectiveness and safety of this mechanical
      percussion device in the treatment of airway clearance with conventional chest physiotherapy
      carried out by qualified physiotherapists in patients suffering from bronchiectasis or
      Chronic obstructive Pulmonary disease (COPD).
    

Detailed Description

      This study will compare the amount of sputum expectorated during the two procedures and not
      intended to look at the clinical improvement of the patient.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.

Secondary Outcome

 Change in FEV1 and FVC before and after the two methods of therapy

Condition

Chronic Bronchiectasis

Intervention

Conventional Chest Physiotherapy (CCPT)

Study Arms / Comparison Groups

 Conventional Chest PhysioTherapy
Description:  Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

December 2011

Completion Date

June 2012

Primary Completion Date

June 2012

Eligibility Criteria

        Inclusion Criteria:

          1. Adult patients > 18 years of age

          2. Chronic sputum expectoration-(producing >30ml/day of sputum at baseline)

          3. Clinical diagnosis of bronchiectasis or COPD

          4. Not carrying out regular chest physiotherapy (for the purposes of this study this will
             be defined as less than two occasions per week)

          5. Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks
             preceding study entry).

          6. FEV1 of > 35% of the predicted value in COPD patients

        Exclusion Criteria:

          1. Primary diagnosis of asthma;

          2. Active sarcoidosis

          3. Active Pulmonary tuberculosis.

          4. History of brittle bones,

          5. History of broken ribs in the past one year.

          6. History of severe osteoporosis

          7. Bleeding from the lungs or haemoptysis

          8. Experiencing intense pain in the thoracic region

          9. Clinical suspicion of increased intracranial pressure.

         10. Have head or neck injuries

         11. Have collapsed lungs or a damaged chest wall;

         12. Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to
             enrollment)

         13. Have a pulmonary embolism or lung abscess;

         14. Have an active hemorrhage

         15. Have injuries to the spine

         16. Have open wounds or burns in the thoracic region

         17. Have had recent surgery (Within six months prior to enrollment.)

         18. Any systemic steroids within 4/52 prior to enrollment

         19. Any antibiotics within 4/52 prior to enrollment
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ong L Meng, MBBS, FRCP, , 

Location Countries

Malaysia

Location Countries

Malaysia

Administrative Informations


NCT ID

NCT01480882

Organization ID

CT-11-HPP-001

Secondary IDs

NMRR-11-661-10072

Responsible Party

Principal Investigator

Study Sponsor

Penang Hospital, Malaysia


Study Sponsor

Ong L Meng, MBBS, FRCP, Study Chair, Penang Hospital, Malaysia


Verification Date

December 2012